FDA 510(k)

AUSONICS OPUS 2 REALTIME ULTRASOUND SCANNER

K-Number: K933916 · 1994-10-03

Decision Date1994-10-03

Product CodeIYN

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

AUSONICS OPUS 2 REALTIME ULTRASOUND SCANNER is the device name listed in this FDA 510(k) record. The listed applicant is Ausonics Pty , Ltd.. It received FDA 510(k) clearance on 1994-10-03 under 510(k) number K933916. The device is classified under product code IYN. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AUSONICS OPUS 2 REALTIME ULTRASOUND SCANNER?

AUSONICS OPUS 2 REALTIME ULTRASOUND SCANNER is a medical device that received FDA 510(k) clearance on 1994-10-03. The listed applicant is Ausonics Pty , Ltd.. The 510(k) number is K933916.

When did AUSONICS OPUS 2 REALTIME ULTRASOUND SCANNER receive FDA 510(k) clearance?

AUSONICS OPUS 2 REALTIME ULTRASOUND SCANNER received FDA 510(k) clearance on 1994-10-03, under 510(k) number K933916.

Who is the listed applicant for AUSONICS OPUS 2 REALTIME ULTRASOUND SCANNER?

The FDA 510(k) record lists Ausonics Pty , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for AUSONICS OPUS 2 REALTIME ULTRASOUND SCANNER?

The FDA product code for AUSONICS OPUS 2 REALTIME ULTRASOUND SCANNER is IYN.

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Other records listing Ausonics Pty , Ltd. as applicant

K915715CINE RECALL FUNCTION/OPUS 1 REAL TIME SCANNER K920307AUSONICS OPUS 1 SYSTEM, ANNULAR ARRAY OPTION K905488DOPPLER UPGRADE FOR AUSONICS OPUS 1 REAL TIME SCAN K9027287.5 MHZ BI PLANE RECTAL PROBE (P/N: 041-815)K896714AUSONICS 5000 K881979RESUBMITTAL OF MI 1000C MICROIMAGER

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Related Devices (Code: IYN)

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.